The objective of this randomized, single blind trial is to investigate the effect of efficacy of prolotherapy vs. methylprednisolone acetate injection in the treatment of plantar fasciitis. In this study, 30 patients aged 18-70 years old with clinical diagnosis of plantar fasciitis in the past 6 months who meet the inclusion/exclusion criteria will be recruited and randomly assigned into intervention or control group. The patients in the intervention group will receive 1 ml of 2% lidocaine (20 mg/ ml) and 1 ml of 50% dextrose (25 g/50 ml) (dextrose monohydrate 500 mg) giving a 25% dextrose solution. Injection is performed through tender point with a rigid 27G needle. The patients in the control group will receive 1 ml steroid solution injection contained 40mg/ml methylprednisolone and 1 ml of 2% lidocaine. Pain intensity is measured before and 2 and 6 weeks following treatment by Visual Analogue Scale (VAS) and compared between the groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201108157323N2
Registration date:2011-11-15, 1390/08/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-11-15, 1390/08/24
Registrant information
Name
Mohsen Tajalli
Name of organization / entity
Shiraz University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 71 1231 9040
Email address
tajallim@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
medical university of shiraz
Expected recruitment start date
2011-10-07, 1390/07/15
Expected recruitment end date
2012-02-04, 1390/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of prolotherapy vs. methylprednisolone acetate injection in the treatment of chronic plantar fasciitis
Public title
Efficacy of dextrose 25% injection vs. steroid injection in the treatment of heel spur
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 18-70 years old, clinical diagnosis of plantar fasciitis in the past 6 months, Diagnosis of plantar fasciitis was on the basis of pain at, or around, the plantar surface of the heel or the medial longitudinal arch,
Exclusion criteria: chronic plantar fasciitis with systemic symptoms, evidence of pathologic disorders in laboratory data or radiograph of foot, steroid or prolotherapy drug solution injection in 3 months prior to the study, severe co-existing disease such as diabetes, inflammatory arthritis or previous foot surgery
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences and Health Services
Street address
Zand avenue
City
Shiraz
Postal code
Approval date
2011-10-06, 1390/07/14
Ethics committee reference number
CT-90-2112
Health conditions studied
1
Description of health condition studied
plantar fascitis
ICD-10 code
M72.2
ICD-10 code description
plantar fascitis
Primary outcomes
1
Description
pain intensity
Timepoint
befor intervention; 2 and 6 weeks after intervention
Method of measurement
Visual Analogue ScaLe(VAS)
Secondary outcomes
1
Description
side effects
Timepoint
second and sixth weeks
Method of measurement
examination, side effects such as rupture of ligament, heel pad atrophy, hypopigmentation
Intervention groups
1
Description
Control Group : A 2.5 ml syringe is filled with 1 ml steroid solution injection contained 40mg/ml methylprednisolone and 1 ml of 2% lidocaine.
Category
Treatment - Other
2
Description
prolotherapy Group: A 2.5 ml syringe is filled with 1 ml of 2% lidocaine (20 mg/ ml) and 1 ml of 50% dextrose (25 g/50 ml) (dextrose monohydrate 500 mg) giving a 25% dextrose solution. Injection is performed through tender point with a rigid 27G needle .
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Rehabilitation ward, Shahid Chamran Hospital
Full name of responsible person
Dr. Mohsen Tajalli
Street address
Chmran avenue
City
Shiraz
2
Recruitment center
Name of recruitment center
Rehabilitation ward, Shahid Dr. Fahgehi Hospital
Full name of responsible person
Dr. Mohsen Tajalli
Street address
Zand avenue
City
Shiraz
3
Recruitment center
Name of recruitment center
Rehabilitation ward, Hafez Hospital
Full name of responsible person
Dr. Mohsen Tajalli
Street address
Chmran avenue
City
Shiraz
4
Recruitment center
Name of recruitment center
Rehabilitation ward, Shahid Motahari Hospital
Full name of responsible person
Dr. Mohsen Tajalli
Street address
Namazi square
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences and Health Services
Full name of responsible person
Kambiz Eskandari
Street address
Zand avenue
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences and Health Services
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences and Health Services
Full name of responsible person
Dr. Mostafa Jazayeri Shoshtari
Position
Associate Professor of Physical Medicine and Rehabilitation
Other areas of specialty/work
Street address
Zand avenue
City
Shiraz
Postal code
Phone
+98 71 1231 9040
Fax
Email
jazayeri1335@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences and Health Services
Full name of responsible person
Dr. Mohammadreza Emad
Position
Associate Professor of Physical Medicine and Rehabilitation
Other areas of specialty/work
Street address
Zand avenue
City
Shiraz
Postal code
Phone
+98 71 1231 9040
Fax
Email
emadm@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences and Health Service
Full name of responsible person
Dr. Alireza Ashraf
Position
Associate Professor of Physical Medicine and Rehabilitation/
Other areas of specialty/work
Street address
Zand avenue
City
Shiraz
Postal code
Phone
+98 71 1231 9040
Fax
Email
ashrafa@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)